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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5275 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 5275

 To amend title XVIII of the Social Security Act to facilitate patient 
               access to certain pediatric technologies.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           September 25, 2024

Mrs. Blackburn introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL

 
 To amend title XVIII of the Social Security Act to facilitate patient 
               access to certain pediatric technologies.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Access to Pediatric Technologies Act 
of 2024''.

SEC. 2. FACILITATING ACCESS TO PEDIATRIC TECHNOLOGIES.

    (a) In General.--Section 1848 of the Social Security Act (42 U.S.C. 
1395w-4) is amended by adding at the end the following new subsection:
    ``(u) Facilitating Access to Pediatric Technologies.--
            ``(1) In general.--For each qualifying pediatric technology 
        (as defined in paragraph (4)) furnished on or after January 1, 
        2026, the Secretary shall, upon receipt of a manufacturer 
        request under paragraph (3), establish national relative value 
        units under the physician fee schedule established under this 
        section, to the extent no such national relative value units 
        have been established for such qualifying pediatric technology 
        under such fee schedule.
            ``(2) Payment methodology.--The Secretary shall establish 
        national relative value units for a qualifying pediatric 
        technology under this subsection--
                    ``(A) in accordance with the payment methodology 
                established under this section and applicable 
                regulations; and
                    ``(B) using available data related to the 
                qualifying pediatric technology, which may include 
                applicable contractor pricing information, claims data, 
                time and motion studies, invoice information, or other 
                information used by the Secretary in establishing 
                payment rates.
            ``(3) Implementation.--
                    ``(A) In general.--Upon written request to the 
                Secretary from the manufacturer of a qualifying 
                pediatric technology, the Secretary shall establish 
                national relative value units under paragraph (1) 
                through the annual rulemaking process for the physician 
                fee schedule established under this section, in 
                accordance with the timeline described in subparagraph 
                (B).
                    ``(B) Timeline.--
                            ``(i) In the case where the Secretary 
                        receives a request under this paragraph on or 
                        before May 1 of a given year from a 
                        manufacturer with respect to a qualifying 
                        pediatric technology of the manufacturer, the 
                        Secretary shall establish national relative 
                        value units for the qualifying pediatric 
                        technology in the rulemaking process during 
                        that year for the physician fee schedule 
                        established under this section.
                            ``(ii) In the case where the Secretary 
                        receives a request under this paragraph after 
                        May 1 of a given year from a manufacturer with 
                        respect to a qualifying pediatric technology of 
                        the manufacturer, the Secretary shall establish 
                        national relative value units for the 
                        qualifying pediatric technology in the 
                        rulemaking process during the following year 
                        for the physician fee schedule established 
                        under this section.
                    ``(C) Content of manufacturer requests.--A 
                manufacturer submitting a request under paragraph with 
                respect to a qualifying pediatric technology of the 
                manufacturer shall include in such request information 
                to verify that the technology is a qualifying pediatric 
                technology and to allow the Secretary to establish 
                national relative value units for such technology, 
                including (to the extent available) contractor pricing 
                information, claims data, time and motion studies, 
                invoice information, or other relevant information.
            ``(4) Qualifying pediatric technology defined.--In this 
        subsection, the term `qualifying pediatric technology' means a 
        medical device that is--
                    ``(A) covered under this title;
                    ``(B) approved, cleared, or authorized under 
                section 510(k), 513(f)(2), or 515 of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c(f)(2), 
                360e);
                    ``(C) described by a temporary Level I HCPCS Code 
                intended for emerging technologies, services, or 
                procedures; and
                    ``(D)(i) used as part of a procedure predominantly 
                performed on pediatric patients; or
                    ``(ii) has otherwise been specifically designed for 
                safe and effective use in pediatric populations.
            ``(5) Rule of construction.--Nothing in this subsection 
        shall be construed to require coverage of a qualifying 
        pediatric technology under this title or alter the requirements 
        of section 1862(a)(1)(A).''.
                                 <all>
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